Chronic hepatitis C (genotype 1). Infections and Infestations Hepatitis
Conditions
Interventions
This is a prospective, 3:1 randomized, multicenter, double-blind, placebo-controlled, parallel-group study of four courses of 8 + 6 + 6 + 6 IM injections of 50 µg E1y over 157 weeks in 122 genotype 1
Sponsors
Innogenetics NV (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients 18 to 70 years old with compensated chronic hepatitis C genotype 1 infection 2. Female patients of childbearing potential should use an efficient method of contraception 3. Patients should either have failed to respond to interferon (IFN)-based therapy or have contraindications to IFN-based therapy or have decided not to start IFN-based treatment (after having been well informed)
Exclusion criteria
Exclusion criteria: 1. Prior (within last 3 months) or planned concomitant use of other hepatitis C treatment, immunosuppressive, or hepatotoxic treatment 2. Malnutrition or severe medical conditions or medical conditions associated with immunosuppression, including end stage renal failure or cancer 3. Severe symptomatic cryoglobulinemia, active autoimmune hepatitis, uncontrolled diabetes, or uncontrolled thyroid disease 4. HIV infection, active hepatitis B infection 5. Alcohol or intravenous drug abuse during the last year 6. Ongoing medical condition associated with chronic liver disease other than hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver histology (Ishak score) difference from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Other histology assessments 2. Virological, immunological, and biochemical responses 3. Quality of life 4. Safety evaluation | — |
Countries
Belgium
Outcome results
None listed